Reducing bias in trials due to reactions to measurement: experts produced recommendations informed by evidence

David P French; Lisa M Miles; Diana Elbourne; Andrew Farmer; Martin Gulliford; Louise Locock; Stephen Sutton; Jim McCambridge; MERIT Collaborative Group

doi:10.1016/j.jclinepi.2021.06.028

Reducing bias in trials due to reactions to measurement: experts produced recommendations informed by evidence

J Clin Epidemiol. 2021 Nov:139:130-139. doi: 10.1016/j.jclinepi.2021.06.028. Epub 2021 Jul 3.

Authors

David P French¹, Lisa M Miles², Diana Elbourne³, Andrew Farmer⁴, Martin Gulliford⁵, Louise Locock⁶, Stephen Sutton⁷, Jim McCambridge⁸; MERIT Collaborative Group

Collaborators

MERIT Collaborative Group:
Prof Peter Bower⁹, Dr Stacy Clemes¹⁰, Prof Mark Conner¹¹, Ms Ruth Dundas¹², Prof Diana Elbourne¹³, Prof Sandra Eldridge¹⁴, Prof Andrew Farmer¹⁵, Prof David French¹⁶, Prof Carrol Gamble¹⁷, Prof Martin Gulliford¹⁸, Prof Frank Kee¹⁹, Prof Alastair Leyland²⁰, Prof Louise Locock²¹, Dr Rebecca Lynch²², Prof Graeme MacLennan²³, Prof Jim McCambridge²⁴, Dr Lisa Miles²⁵, Dr Samuel Cs Rowley²⁶, Prof Linda Sharples²⁷, Prof Falko F Sniehotta²⁸, Dr Claire Snowdon²⁹, Prof Mirjam Sprangers³⁰, Prof Stephen Sutton³¹

Affiliations

¹ Manchester Centre for Health Psychology, University of Manchester, Oxford Road, Manchester, UK. Electronic address: david.french@manchester.ac.uk.
² Manchester Centre for Health Psychology, University of Manchester, Oxford Road, Manchester, UK.
³ Department of Medical Statistics, London School of Hygiene and Tropical Medicine, Keppel Street, London, UK.
⁴ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
⁵ School of Population Health and Environmental Sciences, King's College London, London, UK.
⁶ Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
⁷ Behavioural Science Group, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
⁸ Department of Health Sciences, University of York, York, UK.
⁹ Professor of Health Services Research, University of Manchester, Manchester, UK.
¹⁰ Reader in Active Living and Public Health, University of Loughborough, Loughborough, UK.
¹¹ Professor of Applied Social Psychology, University of Leeds, Leeds, UK.
¹² Senior Research Fellow, University of Glasgow, Glasgow, UK.
¹³ Professor of Healthcare Evaluation, London School of Hygiene and Tropical Medicine, London, UK.
¹⁴ Professor of Biostatistics, Queen Mary University of London, London, UK.
¹⁵ Professor of General Practice, University of Oxford, Oxford, UK.
¹⁶ Professor of Health Psychology, University of Manchester, Manchester, UK.
¹⁷ Director of the Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.
¹⁸ Professor of Public Health, King's College, London, UK.
¹⁹ Professor of Public Health Medicine, Queens University Belfast, Belfast, UK.
²⁰ Associate Director MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.
²¹ Professor of Health Services Research, University of Aberdeen, Aberdeen, UK.
²² Research Fellow, King's College, London, UK.
²³ Director of Clinical Trials Unit, University of Aberdeen, Aberdeen, UK.
²⁴ Professor of Addictive Behaviours and Public Health, University of York, York, UK.
²⁵ Research Associate, University of Manchester, Manchester, UK.
²⁶ Programme Manager, Medical Research Council, London, UK.
²⁷ Professor of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
²⁸ Director of the NIHR Policy Research Unit Behavioural Science, University of Newcastle, Newcastle upon Tyne, UK.
²⁹ Associate Professor, London School of Hygiene and Tropical Medicine, London, UK.
³⁰ Professor in Medical Psychology, Amsterdam University Medical Centers, Amsterdam, Netherlands.
³¹ Professor of Behavioural Science, University of Cambridge, Cambridge, UK.

Abstract

Objective: This study (MEasurement Reactions In Trials) aimed to produce recommendations on how best to minimize bias from measurement reactivity (MR) in randomized controlled trials of interventions to improve health.

Study design and setting: The MERIT study consisted of: (1) an updated systematic review that examined whether measuring participants had effects on participants' health-related behaviors, relative to no-measurement controls, and three rapid reviews to identify: (i) existing guidance on MR; (ii) existing systematic reviews of studies that have quantified the effects of measurement on behavioral or affective outcomes; and (iii) studies that have investigated the effects of objective measurements of behavior on health-related behavior; (2) a Delphi study to identify the scope of the recommendations; and (3) an expert workshop in October 2018 to discuss potential recommendations in groups.

Results: Fourteen recommendations were produced by the expert group to: (1) identify whether bias is likely to be a problem for a trial; (2) decide whether to collect data about whether bias is likely to be a problem; (3) design trials to minimize the likelihood of this bias.

Conclusion: These recommendations raise awareness of how and where taking measurements can produce bias in trials, and are thus helpful for trial design.

Keywords: Bias; Measurement reactions; Reactivity; Recommendations; Research design; Trials.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Biomedical Research / standards*
Biomedical Research / statistics & numerical data
Data Accuracy*
Guidelines as Topic*
Humans
Publication Bias*
Publications / standards*
Publications / statistics & numerical data
Randomized Controlled Trials as Topic / standards*
Randomized Controlled Trials as Topic / statistics & numerical data
Research Report / standards*

Abstract

Publication types

MeSH terms

Grants and funding